NewLink HyperAcute-Pancreas Immunotherapy wins orphan drug status in Europe

By PBR Staff Writer

NewLink Genetics HyperAcute-Pancreas Immunotherapy (algenpantucel-L) has gained European orphan designation.

Orphan designation provides NewLink with access to multiple incentives for drug development in EU.

Incentives include decreased development costs, right to use to the centralized authorization procedure, 10-year market exclusivity besides condensed marketing authorization application, pre-marketing inspections and multiple post-approval fees.

NewLink Genetics CEO and chairman Dr. Charles Link said, “As emphasized during National Pancreatic Cancer Awareness Month in November, there is a desperate need for new treatment options for this disease and the European Commission’s decision to grant orphan drug designation to algenpantucel-L should help us to address this unmet medical need.”

The company is presently studying Algenpantucel-L in IMPRESS trial in stage I and stage II surgically-resected pancreatic cancer patients.

Algenpantucel-L earlier gained orphan drug designation and Fast-track status in the US.

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